WOBURN, Mass. and OXFORD, U.K., July 22,
2021 /PRNewswire/ -- Rational Vaccines, a company
focused on revolutionizing the treatment of herpes to eradicate the
disease, today announced that it has been awarded an Innovation
Passport under a new process in the United Kingdom (UK) to bring innovative
medicines more rapidly to patients. The Company has received the
Innovation Passport for RVx201, a live-attenuated therapeutic
vaccine being developed for genital herpes resulting from the
herpes simplex type 2 (HSV-2) virus. RVx201 is a first-in-human
HSV-2 live-attenuated therapeutic vaccine that is modified to be
interferon sensitive and destroy the ability of the virus to
inhibit immune responses.
The Innovation Passport is awarded by the UK's Innovative
Licensing and Access Pathway (ILAP) Steering Group, consisting of
the Medicines and Healthcare products Regulatory Agency (MHRA),
National Institute for Health and Care Excellence (NICE), and the
Scottish Medicines Consortium (SMC). RVx201 is the first vaccine
for HSV-2 to be awarded this designation under ILAP, which was
launched by MHRA in January 2021.
"Herpes affects billions of people worldwide and has been shown
to interact with other pandemic pathogens, worsening their impact
and transmissibility, including HIV. Given the wide reach of the
herpes virus and its implications for people of all ages around the
globe, advancing a vaccine is critical," said Agustin Fernandez III, chief executive officer,
Rational Vaccines. "For the first time, genital herpes is
recognized as a seriously debilitating disease by a leading
medicines regulator. This award shows the MHRA's commitment to
properly addressing the severe disease burden of so many people
with herpes worldwide. This designation is the first step in a
program of regulatory optimization that Rational Vaccines has
initiated to allow us to move RVx201 into the clinic in the
swiftest and most effective way possible. We look forward to
continuing to work with the MHRA and other regulatory bodies around
the world as we fulfill our core mission of helping patients
suffering from herpes and herpes-related diseases and eradicating
the virus globally."
"Herpes remains one of the most devastating infections in the
world that can lead to blindness and death, particularly in
neonatal and pediatric populations. At present there is a lack of
novel, safe and effective treatment options beyond antiviral drugs
that were discovered in the 1970s by UK-based Burroughs Wellcome
[later GSK]i. Today, fifty years on from these studies,
Rational Vaccines is delighted to lead a new chapter of HSV
treatment research in the UK supported by worldwide partners. The
MHRA's robust oversight standards and innovative approach to
regulatory affairs were key drivers in RVx's decision to invest in
UK clinical development activities, as a platform to international
expansion," said Dr. David
Brindley DPhil, MEng, MBA, PG Cert (IP),
RAC (US), FRSA, FRSB, chief
regulatory and IP officer, Rational Vaccines. "The granting of an
Innovation Passport and entry into ILAP for RVx201 for the
treatment of HSV-2 genital herpes represents a significant
milestone for Rational Vaccines as it recognizes the potential of
our approach to transform herpes treatment. We look forward to
advancing our RVx201 therapeutic program into the clinic."
The MHRA launched ILAP at the start of 2021 to accelerate the
development and access to promising medicines in the UK, thereby
facilitating and improving patient access to new
medicines. The pathway, part of the UK's plan to extend the
UK's position as an international leader in life sciences, features
enhanced input and interactions with the MHRA and other
stakeholders, including NICE and the SMC. Such regulatory
innovations are complemented by the UK's commitment to "[Sustain
the UK's] position in novel vaccine discovery, development,
manufacture and use of vaccines" as outlined in the recently
announced HM Government Life Science Visionii; an
ambition that Rational Vaccines supports.
To receive an Innovation Passport, an experimental drug needs to
meet the following public health and/or patient-centric criteria:
(1) the condition is life-threatening or seriously debilitating;
(2) the program fulfills at least one of the following: innovative
medicine, clinically significant new indication or, it is intended
for a special population; and (3) the medicine has the potential to
offer benefits to patients. The Innovation Passport designation is
the first step in the ILAP process. It triggers the MHRA and its
partner agencies to create a target development profile to chart
out a roadmap for regulatory and development milestones with the
goal of early patient access in the UK. Other benefits of ILAP
include a 150-day accelerated assessment, rolling review, and a
continuous benefit-risk assessment.
Rational Vaccines was advised by Niche Science and Technology
Ltd and Covington and Burling LLP for the Company's ILAP Innovation
Passport application.
About RVx201
RVx201 is a first-in-human herpes simplex virus type 2 (HSV-2)
live-attenuated therapeutic vaccine that is modified to be
interferon sensitive and destroy the ability of the virus to
inhibit immune responses. In preclinical animal models, data have
shown that RVx201 is safe and does not establish latency, and the
vaccine's immunization protects against lethal challenge with
virulent HSV-2 strains.
About Herpes Simplex Virus (HSV)
The herpes simplex
virus (HSV), commonly referred to as herpes, is categorized into
two types: herpes simplex virus type 1 (HSV-1) and herpes simplex
virus type 2 (HSV-2). HSV-1 is the primary cause of oral herpes but
can also cause genital herpes. HSV-2 is the primary cause of
genital herpes. According to a 2020 report by the World Health
Organization (WHO), herpes infects billions globally – about a half
a billion people worldwide are living with genital herpes, and
several billion have an oral herpes infection. Both HSV-1 and HSV-2
infections are lifelong.
While some herpes infections are asymptomatic, a significant
number of people experience a range of symptoms that vary in
frequency and severity. The most common symptoms for both types of
herpes are painful blisters or ulcers at the infection site. In
addition, many patients experience debilitating neuralgia, skin
splits, fissures, minor abrasions, erythema, fever, chills, and
myalgias. Both viruses are most contagious during a symptomatic
outbreak, but they can still be transmitted in the absence of
symptoms. Beyond physical symptoms, herpes patients often suffer
from social stigma and isolation because the infection is often
transmitted sexually. Strong evidence has emerged that HSV-1 is a
major risk factor for Alzheimer's disease.
There is no cure for herpes. There are no approved vaccines or
immunotherapies or sufficiently reliable diagnostics currently
available. Antiviral medications developed in the 1970s can help to
reduce the severity and frequency of symptoms but cannot cure the
infection.
Herpes and HIV
People with compromised immune systems,
such as those with advanced HIV infection, are impacted by herpes:
HSV-1 symptoms can be more severe and recur more frequently for
people with HIV; and HSV-2 fuels the HIV epidemic by increasing the
risk of acquiring and transmitting a new HIV infection three-fold.
Of particular note, the WHO reports that women living in the WHO
Africa Region have the highest HSV-2 prevalence and exposure to HIV
– putting them at greatest risk of HIV infection.
Neonatal HSV
Neonatal HSV-1 or HSV-2 are both
potentially devastating, leading to serious health problems for the
newborn and if left untreated, can lead to an 85 percent mortality
rate among infected infants. Although typically acquired at the
time of delivery when the risk of transmission from an infected
mother is high, as the infant is exposed to the herpes virus in the
genital tract during delivery, it can also be transmitted
post-delivery. Infants exposed at birth can suffer from fatal organ
damage, serious viral infections, sores, blindness, deafness, and
seizures.
About Rational Vaccines
Rational Vaccines is
revolutionizing the treatment, prevention, and diagnosis of herpes
and herpes-related diseases with its rationally engineered,
live-attenuated viral immunotherapeutic and prophylactic vaccine
candidates. Led by a team of world-renowned scientists, the Company
is headquartered in Woburn, MA
with locations in Miami, FL and
Oxford, UK. For more information,
please visit www.rationalvaccines.com.
i
https://www.jaad.org/article/S0190-9622(88)70022-5/pdf
ii
https://www.gov.uk/government/publications/life-sciences-vision
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